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Preparations for pivotal-stage readiness of vididencel in AML on track

The hard work of the Mendus team to advance the company’s lead product vididencel in acute myeloid leukemia (AML) continued to pay off during the  fourth quarter of 2024.

In December, we presented positive updated survival data of the ongoing ADVANCE II Phase 2 trial at ASH, demonstrating that the majority of patients treated remained alive at 41.8 months median follow-up. Also in Q4, we received positive EMA and FDA feedback endorsing our registration trial preparations. We successfully advanced our manufacturing alliance for the large-scale production of vididencel. The progress realized during the quarter keeps us on track to achieve pivotal-stage readiness of vididencel in AML as our lead program in the second half of 2025.

Erik Manting, CEO

AML is an aggressive from of blood cancer which yearly affects about 50,000 people in Europe and the US only and 145,000 people globally. It is a highly deadly disease, with a 5-year survival rate of approximately 30%. The only potential curative approach for AML is a hematopoietic stem cell transplant (HSCT) following successful chemotherapy, but this is not available for the majority of patients. In the Phase 2 ADVANCE II trial, AML patients that were in complete remission following high-intensity chemotherapy were treated with vididencel. All patients had measurable residual disease (MRD), which is associated with an increased risk of disease relapse and poor overall survival. Mendus presented updated survival data of the ADVANCE II trial during the American Society of Hematology (ASH) conference last December. The data showed that the majority (13/20) of patients treated with vididencel were alive at a median follow-up of 41.8 months. Immunological analyses of patient samples collected during the trial showed that durable clinical remissions were associated with broad immune responses detected after vididencel treatment, confirming the product’s mode of action as an active immunotherapy in AML.

The positive updated Phase 2 survival data presented at ASH support our ongoing registration trial preparations for vididencel in AML. In Q4, Mendus received feedback on its development program for vididencel in an end-of-Phase 2 meeting held with US Food and Drug Administration (FDA) and a Scientific Advice Meeting with the European Medicines Agency (EMA). The feedback from both agencies supported the registration trial design, patient population, reference therapy, primary and secondary endpoints and statistical analysis strategy, as proposed by Mendus. The agencies also agreed to the development steps taken by Mendus towards establishing large-scale manufacturing of vididencel. To support late-stage clinical development and future commercialization, Mendus has entered into a large-scale manufacturing alliance with NorthX Biologics, a specialized contract manufacturing organization. The alliance is on track, with multiple consecutive large-scale production runs having been completed successfully and production of clinical-grade material expected in the second half of 2025.

In addition to preparing for pivotal-stage readiness of vididencel as a post-chemotherapy maintenance treatment for MRD+ AML patients, Mendus is aiming to broaden the potential of vididencel by expanding its clinical development. We continue to work with the Australasian Leukaemia and Lymphoma Group (ALLG) to study vididencel in combination with oral azacitidine, currently the only approved AML maintenance treatment, for both MRD+ and MRD- patients in the AMLM22-CADENCE trial. The collaboration with ALLG significantly expands Mendus’ clinical trial network and the data collected in the CADENCE trial will contribute to the safety dossier of vididencel, supporting Mendus’ registration trial preparations. Two preclinical abstracts presented at ASH focused on the applicability of vididencel in additional patient populations. AML patients not eligible for high-intensity chemotherapy can today be treated with a combination of azacitidine (AZA) and venetoclax (VEN). A series of preclinical experiments demonstrated that vididencel acts synergistically with AZA+VEN, supporting potential clinical evaluation of vididencel as a maintenance therapy also in this patient population. The second preclinical abstract presented at ASH studied vididencel in chronic myeloid leukemia (CML). In CML, stimulation of active immunity against residual cancer cells with vididencel may allow for more patients to control their disease without the need for life-long medication. Subject to funding, Mendus is preparing for additional vididencel trials which may further broaden the addressable patient population in AML and adjacent diseases, such as CML.

Positive topline data from the ALISON Phase 1 clinical trial with vididencel in high-grade serous ovarian cancer performed by the UMC Groningen, The Netherlands, were reported in December. The data demonstrated vididencel-induced immune responses against ovarian cancer antigens in the majority of patients and confirmed vididencel’s strong safety profile in this indication. The majority of patients with vididencel-induced immune responses had stable disease at week 22 from start of treatment (8 out of 12 patients, or 67%). A next update of the ALISON trial based on 2-year survival follow-up is expected in the fourth quarter of 2025, after which we expect to be in a position to assess potential clinical benefit of vididencel in ovarian cancer.

In our earlier-stage pipeline, we encountered a setback for the intratumoral immune primer ilixadencel, as we were notified during Q4 by our partner Institut Bergonié that third party funding for the REGOMUNE trial had been terminated. Mendus and Institut Bergonié were preparing to study ilixadencel in soft tissue sarcomas as part of the REGOMUNE trial, but due to the lack of funding Institut Bergonié is no longer in a position to proceed with the collaboration. As a result, Mendus has decided to not pursue additional trials with ilixadencel at this moment and focus will be put on potential partnering of this program.

The company is in a strong position as we start 2025. Our Phase 3 trial preparations are on track thanks to the continued positive Phase 2 data presented at ASH, supportive feedback from regulatory authorities and progress towards large-scale production of vididencel. In addition, we are preparing the route to broaden the addressable patient population in AML and other blood-borne tumors. We look forward to keeping our stakeholders informed of our progress in 2025.

Thank you for your continued interest in Mendus.

Erik Manting, Ph.D.
Chief Executive Officer

 

*Published on February 13, 2025